Desloratadine as Add-On Therapy for Rheumatoid Arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will add desloratadine 5 mg daily to participants' usual DMARD regimen for 12 weeks to see if it lowers RA activity and inflammatory markers. Participants with active RA (DAS28 > 2.6), aged 18–60, on methotrexate, will be assigned to desloratadine or placebo in parallel groups. Outcomes will include disease activity scores, inflammatory biomarkers, and patient-reported measures, with safety monitored throughout. If desloratadine shows benefit and tolerability, it could support a novel adjunctive approach for RA management. The study leverages prior evidence of anti-inflammatory effects beyond antihistamine action, explored in a controlled RA population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.
* Disease Activity Score in 28 joints (DAS28) greater than 2.6.
* Age between 18 and 60 years.
* Male and female patients.
* Patients receiving methotrexate in addition to standard conventional therapy.
* Ability to provide written informed consent.

Exclusion Criteria:

* Patients with renal or hepatic disease.
* Known hypersensitivity to the study medications.
* Current use of antioxidant supplements.
* History of psychiatric disorders.
* Use of oral prednisolone at a dose greater than 15 mg per day.
* Current treatment with biological disease modifying antirheumatic drugs.
* Pregnant or breastfeeding patients.
* History of cardiac arrhythmias or prolonged QT interval.
* Use of medications known to prolong the QT interval.

Where it's running

• Faculty of medicine, Mansoura University
  Al Mansurah, Egypt Recruiting

Study contacts

• Principal investigator: Amira Mashaly — Horus University
• Study coordinator: Amira Mashaly
• Email: amashaly@horus.edu.eg
• Phone: 01028275001

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.